Tezacaftor and Ivacaftor side effects: what 5,284 FDA adverse event reports show
Drug class
Combination of tezacaftor and ivacaftor
Brand names
Symdeko
Who reports
5,284 reports · 62% serious · 74 with death outcome · 58% female
Used for
SYMDEKO is indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence .
What it is
SYMDEKO is co-packaged as a tezacaftor/ivacaftor fixed-dose combination tablet and an ivacaftor tablet. Both tablets are for oral administration. Tezacaftor 50 mg/ivacaftor 75 mg fixed-dose co.
Boxed warning
None in the current label
Causality screen of the 28 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 20 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Haemoptysis | 132 | 18.8 15.9–22.3ROR 19.3 · χ² 2,201 / p <1e-300 | 18.7 EB05 16.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 14.1 | no trial data cached |
| Lung infection | 61 | 15.4 12.0–19.8ROR 15.6 · χ² 805 / p 2e-177 | 15.2 EB05 12.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 | no trial data cached |
| Hospitalisation | 459 | 12.0 11.0–13.1ROR 13.0 · χ² 4,629 / p <1e-300 | 11.9 EB05 11.0 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 | no trial data cached |
| Infection | 352 | 9.7 8.8–10.7ROR 10.3 · χ² 2,752 / p <1e-300 | 9.6 EB05 8.8 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 | no trial data cached |
| Liver function test increased | 48 | 8.9 6.7–11.9ROR 9.0 · χ² 330 / p 4e-74 | 8.5 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · ♀ 33% (drug 58%) | no trial data cached |
| Respiratory tract congestion | 25 | 6.2 4.2–9.2ROR 6.3 · χ² 105 / p 7e-25 | 5.6 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 | no trial data cached |
| Sinus congestion | 20 | 5.9 3.8–9.1ROR 5.9 · χ² 76 / p 1e-18 | 5.2 EB05 3.6 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=4 | no trial data cached |
| Insurance issue | 21 | 5.6 3.7–8.6ROR 5.6 · χ² 75 / p 2e-18 | 5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Viral infection | 41 | 4.9 3.6–6.6ROR 4.9 · χ² 123 / p 6e-29 | 4.6 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Sinus disorder | 24 | 4.8 3.2–7.2ROR 4.8 · χ² 69 / p 6e-17 | 4.4 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 | no trial data cached |
| Pneumothorax | 19 | 4.8 3.0–7.5ROR 4.8 · χ² 53 / p 2e-13 | 4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Lung disorder | 51 | 4.1 3.1–5.4ROR 4.2 · χ² 118 / p 8e-28 | 4.0 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 75% consumer | no trial data cached |
| Productive cough (cough with phlegm) | 49 | 4.1 3.1–5.4ROR 4.1 · χ² 112 / p 2e-26 | 4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 1.8 | no trial data cached |
| Respiratory tract infection | 26 | 4.0 2.7–5.8ROR 4.0 · χ² 55 / p 6e-14 | 3.7 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.2 | no trial data cached |
| Product dose omission | 66 | 4.0 3.1–5.0ROR 4.0 · χ² 143 / p 3e-33 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 7.7 | no trial data cached |
| Pneumonia (lung infection) | 286 | 3.5 3.1–3.9ROR 3.7 · χ² 519 / p 4e-115 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 | no trial data cached |
| Staphylococcal infection | 27 | 3.2 2.2–4.7ROR 3.2 · χ² 40 / p 2e-10 | 3.1 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Bacterial infection | 15 | 3.2 1.9–5.3ROR 3.2 · χ² 21 / p 3e-6 | 3.0 EB05 1.9 · IC025 +0.7 | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Intestinal obstruction | 30 | 3.2 2.2–4.5ROR 3.2 · χ² 43 / p 3e-11 | 3.1 EB05 2.3 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Influenza | 85 | 3.0 2.4–3.7ROR 3.0 · χ² 113 / p 1e-26 | 3.0 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Sinusitis | 75 | 2.9 2.3–3.6ROR 2.9 · χ² 92 / p 5e-22 | 2.9 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Nephrolithiasis (kidney stones) | 32 | 2.8 2.0–3.9ROR 2.8 · χ² 35 / p 2e-9 | 2.7 EB05 2.0 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Treatment noncompliance | 38 | 2.8 2.0–3.8ROR 2.8 · χ² 41 / p 6e-11 | 2.7 EB05 2.1 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| Cough | 183 | 2.6 2.3–3.0ROR 2.7 · χ² 180 / p 2e-41 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Hepatic enzyme increased | 43 | 2.5 1.9–3.4ROR 2.5 · χ² 38 / p 4e-10 | 2.5 EB05 1.9 · IC025 +0.8 | Labeled (related wording) related wording | serious PRR 1.0 · ♀ 37% (drug 58%) | no trial data cached |
| Fungal infection | 21 | 2.5 1.6–3.8ROR 2.5 · χ² 17 / p 1e-5 | 2.4 EB05 1.7 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.0 | no trial data cached |
| Chest discomfort | 61 | 2.4 1.8–3.0ROR 2.4 · χ² 47 / p 3e-12 | 2.3 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.0 | no trial data cached |
| Nasopharyngitis (common cold) | 100 | 2.1 1.8–2.6ROR 2.2 · χ² 61 / p 3e-15 | 2.1 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.1 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hospitalisation | 459 | 12.0 11.0–13.1ROR 13.0 · χ² 4,629 / p <1e-300 | 11.9 EB05 11.0 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 | no trial data cached |
| Infection | 352 | 9.7 8.8–10.7ROR 10.3 · χ² 2,752 / p <1e-300 | 9.6 EB05 8.8 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 | no trial data cached |
| Pneumonia (lung infection) | 286 | 3.5 3.1–3.9ROR 3.7 · χ² 519 / p 4e-115 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 | no trial data cached |
| Cough | 183 | 2.6 2.3–3.0ROR 2.7 · χ² 180 / p 2e-41 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Haemoptysis | 132 | 18.8 15.9–22.3ROR 19.3 · χ² 2,201 / p <1e-300 | 18.7 EB05 16.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 14.1 | no trial data cached |
| Nasopharyngitis (common cold) | 100 | 2.1 1.8–2.6ROR 2.2 · χ² 61 / p 3e-15 | 2.1 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.1 | no trial data cached |
| Influenza | 85 | 3.0 2.4–3.7ROR 3.0 · χ² 113 / p 1e-26 | 3.0 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Sinusitis | 75 | 2.9 2.3–3.6ROR 2.9 · χ² 92 / p 5e-22 | 2.9 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Product dose omission | 66 | 4.0 3.1–5.0ROR 4.0 · χ² 143 / p 3e-33 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 7.7 | no trial data cached |
| Chest discomfort | 61 | 2.4 1.8–3.0ROR 2.4 · χ² 47 / p 3e-12 | 2.3 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.0 | no trial data cached |
| Lung infection | 61 | 15.4 12.0–19.8ROR 15.6 · χ² 805 / p 2e-177 | 15.2 EB05 12.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 | no trial data cached |
| Lung disorder | 51 | 4.1 3.1–5.4ROR 4.2 · χ² 118 / p 8e-28 | 4.0 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 75% consumer | no trial data cached |
| Productive cough (cough with phlegm) | 49 | 4.1 3.1–5.4ROR 4.1 · χ² 112 / p 2e-26 | 4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 1.8 | no trial data cached |
| Liver function test increased | 48 | 8.9 6.7–11.9ROR 9.0 · χ² 330 / p 4e-74 | 8.5 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · ♀ 33% (drug 58%) | no trial data cached |
| Hepatic enzyme increased | 43 | 2.5 1.9–3.4ROR 2.5 · χ² 38 / p 4e-10 | 2.5 EB05 1.9 · IC025 +0.8 | Labeled (related wording) related wording | serious PRR 1.0 · ♀ 37% (drug 58%) | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Haemoptysis — n=132, PRR 18.8
- Lung infection — n=61, PRR 15.4
- Liver function test increased — n=48, PRR 8.9
- Insurance issue — n=21, PRR 5.6
- Viral infection — n=41, PRR 4.9
- Lung disorder — n=51, PRR 4.1
- Productive cough — n=49, PRR 4.1
- Staphylococcal infection — n=27, PRR 3.2
- Sinusitis — n=75, PRR 2.9
- Nephrolithiasis — n=32, PRR 2.8
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Tezacaftor and Ivacaftor?
In FDA FAERS, the most frequently co-reported reaction terms for Tezacaftor and Ivacaftor are infection, pneumonia, cough, haemoptysis, nasopharyngitis, influenza. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Tezacaftor and Ivacaftor have an FDA boxed warning?
No. The FDA label retrieved for Tezacaftor and Ivacaftor has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Tezacaftor and Ivacaftor causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 302ae804-37db-44fd-ac2f-3dbdeda9aa4b, effective 20260821; matched on
openfda.generic_name.exact:"TEZACAFTOR AND IVACAFTOR") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 48 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.